Indian Drug Manufacturers Association (IDMA) sees the need for robust and contemporary processes to be put in place by the pharma industry to sustain management of quality. This is where the Association views William Edwards Deming’s 14 principles to create quality-conscious organizations that will help in facing the inspection challenges successfully.
The Association has also pointed out that the industry requires strong and responsive systems relevant to the current times to offset unprecedented compliance challenges during global regulatory inspections.
The way forward for Indian pharma would be to implement a best-in-class Pharmaceutical Quality System (PQS) framework by adopting William Edwards Deming’s 14 principles.
Management Consultant Deming in his book ‘Out of Crisis’, presented 14 principles which included better design of products, improve service, uniform quality, improved product testing in the workplace and in research centers, appreciate systems and understand variations.
According to Daara B Patel secretary general, IDMA, despite achieving a remarkable success in the manufacture and supply of medicines of global quality standards in the domestic as well as export markets, Indian pharma companies continue to face unprecedented compliance challenges. While the issues are similar to those seen in companies across the world, it is time that the Indian industry approaches this concern.
“The industry is lagging behind the compliance. This is where documentation is the need of the hour. It has led IDMA to tackle the situation through extensive exchange of knowhow on adherence to high quality standards, said Patel.
Now IDMA through its Karnataka chapter has kicked off the first seminar to achieve global compliance. The platform enabled the representatives of the state industry to devise a pathway to pharmaceutical quality systems and find solutions to the most pressing issues to achieve and sustain quality standards. Going by the stiff competition in the global markets, there is need to update skills besides focus on quality adherence, said S M Mudda, chairman IDMA-KSB and director, Global Strategy (Technical), Micro Labs.
An analysis of the underlying contributing factors revealed that adoption of PQS and risk-based approach for implementation of GMPs coupled with creating a quality culture is the way forward for manufacturing reliability and regulatory compliance, noted Mudda.
Chipping in his views on the PQS, Patel told Pharmabiz that the most difficult challenges before the industry were to ensure the consistency in product manufacture, documentation of processes and compliance till the last mile.
“We need robust, agile and contemporary processes to create a platform to enable culture of quality,” said Mudda.
For Suresh Khanna, founder-chairman, Stabicon and managing director, Dossier Solutions data integrity is a critical component of pharmaceutical operations. On a similar note Kapil Bhargava, retired deputy drugs controller (India), CDSCO, said that the way forward was to go back to basics of quality where pharma industry personnel should avoid short-cuts and manipulate data.
Karnataka drugs controller B T Khanapure who was the chief guest for the IDMA KSB event said that self inspections, effective implementation of GMP and avoidance of cross contamination would ensure reliability in drug manufacturing.